(72 days)
Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.
These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.
The provided document is a 510(k) premarket notification for 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study designed to establish new acceptance criteria and prove performance against them.
Therefore, many of the requested elements for describing an acceptance criteria study are not directly available in this type of document. Specifically, there is no detailed information on a clinical trial or performance study that would generate acceptance criteria and report device performance against them in the format requested.
However, I can extract information related to the device's claims and the type of testing performed to support its safety.
Here's a breakdown of what can be inferred or explicitly stated from the document, acknowledging the limitations inherent in a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present acceptance criteria and reported device performance in a quantitative table as typically seen in a dedicated performance study. The 510(k) process focuses on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. The "performance" here is primarily an assertion that it meets the safety profile and intended use of the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of a clinical performance study with acceptance criteria. The document mentions "Biocompatibility test results presented in Attachment 4," but details like sample size for these biocompatibility tests are not provided in the summary.
- Data Provenance: The biocompatibility testing likely occurred in a laboratory setting. The country of origin for the manufacturing company is the United Kingdom. Whether the biocompatibility data originates from the UK or elsewhere is not specified. The document does not describe retrospective or prospective clinical studies to evaluate performance against acceptance criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" in a 510(k) for a dressing is typically established through regulatory standards, predicate device performance, and laboratory testing for characteristics like biocompatibility, sterility, etc. There's no mention of a test set requiring expert adjudication for a "ground truth" as would be the case for diagnostic accuracy studies.
4. Adjudication Method for the Test Set:
Not applicable for this type of submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or reported in this document. This type of study focuses on improving human reader performance with AI assistance, which is outside the scope of an alginate wound dressing's submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No, this is not relevant for an alginate wound dressing. This concept applies to AI/ML software as a medical device.
7. Type of Ground Truth Used:
For the safety claims, the "ground truth" would be established by:
- Biocompatibility testing standards: These tests (e.g., cytotoxicity, sensitization, irritation) assess the device's interaction with biological systems. The results are compared against established benchmarks for safety, rather than an "expert consensus."
- Predicate device characteristics: Substantial equivalence relies on comparing the new device's materials, design, intended use, and performance claims to a legally marketed predicate device (K953781). The predicate's established safety and effectiveness serve as a form of "ground truth" for comparison.
8. Sample Size for the Training Set:
Not applicable. This document does not describe the development or training of an algorithm or AI system.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of Device Performance (from the document):
While not a quantitative table with pre-defined acceptance criteria, the document states:
- Biocompatibility: "Biocompatibility test results presented in Attachment 4 support the safety of this product for it's stated intended use." This implicitly means the device met accepted benchmarks for biocompatibility.
- Intended Use: The device is deemed "substantially equivalent" to a predicate for its intended use on partial and full thickness wounds with moderate to heavy exudate (e.g., pressure ulcers, venous ulcers, diabetic ulcers, donor sites, trauma wounds, dermal lesions) and to help control minor bleeding. This means its performance in these areas is considered comparable to the predicate.
Key takeaway: This document is a regulatory submission for premarket notification (510(k)), not a detailed performance study with explicit acceptance criteria for a novel device. Its purpose is to demonstrate that the new device is as safe and effective as a previously cleared predicate device, largely through comparison of materials, design, and intended use, supported by general safety testing like biocompatibility.
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MAY 2 7 1998
Image /page/0/Picture/2 description: The image shows the letters "IT" next to a circular logo. The logo is divided into two halves, with the top half being white and the bottom half being black. A cross is centered in the circle, with the top of the cross extending into the white half and the bottom of the cross extending into the black half. The letters "IT" are in a bold, sans-serif font.
Innovative Technologies Ltd
Summary of Safety and Effectiveness for 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing
Manufacturer:
Regulatory Affairs Contact:
Telephone:
Date Summary Prepared:
Device Trade Name:
Common or Usual Name:
Classification:
Description:
Intended Use:
Substantial Equivalence:
Testing Summary:
Innovative Technologies, Limited Road Three. Winsford Industrial Estate Cheshire CW7 3PD, United Kingdom
Priscilla Whitehead Cox, Manager
44 1606 863 500
March 2. 1998
3M™ Tegagen™ HI Alginate Dressing , Product Number 901XX Series and 3M™ Tegagen™ HG Alginate Dressing, Product Number 902XX Series.
Alginate Wound Dressings
Wound Dressings, currently unclassified by FDA.
These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.
Tegagen HI and Tegagen HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate. They may be used for pressure ulcers, arterial ulcers, venous ulcers, diabetic ulcers, donor sites, trauma wounds, and other dermal lesions. They also are intended to help control minor bleeding. This product is not designed, sold, or intended for use except as indicated.
Substantial equivalence was provided in 510(k) K953781.
Biocompatibility test results presented in Attachment 4 support the safety of this product for it's stated intended use.
Image /page/0/Picture/28 description: The image shows a logo with the letters "BSI" in the center, above a heart shape with a horizontal line through it. The letters "AE" are on the left side of the logo, and the letters "ME" are on the right side. The logo is black and white and has a circular shape.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or movement.
MAY 2 7 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chris J. Oakes Regulatory Affairs Manager Innovative Technologies Limited Road Three, Winsford Industrial Estate Winsford, Cheshire CW7 3PD, United Kingdom
Re: K980989 Trade Name: 3M Tegagen HI and HG Alginate Dressing Regulatory Class: Unclassified Product Code: KMF Dated: March 2, 1998 Received: March 16, 1998
Dear Mr. Oakes:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
-
- This device may not be labeled as a treatment or a cure for any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
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If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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11980989 510(k) Number (if known):
Device name: 3M Tegagen HI & 3M Tegagen HG Alginate Dressings
Indications For Use:
Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg:
Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions
Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR Over The Counter Use |
|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K980989 |
RH, Office of Device Examation (ODE) ﺗﺎ
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.